UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004762 |
|---|---|
| Receipt number | R000005669 |
| Scientific Title | Clinical trial of preoperative chemoradiotherapy with TS-1 for locally advanced lower rectal cancer |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2013/12/27 11:03:18 |
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Basic information
Public title
Clinical trial of preoperative chemoradiotherapy with TS-1 for locally advanced lower rectal cancer
Acronym
preoperative chemoradiotherapy with TS-1 for rectal cancer
Scientific Title
Clinical trial of preoperative chemoradiotherapy with TS-1 for locally advanced lower rectal cancer
Scientific Title:Acronym
preoperative chemoradiotherapy with TS-1 for rectal cancer
Region
| Japan |
Condition
Condition
locally advanced lower rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety and efficacy of preoperative chemoradiothrapy with TS-1, surgical resection, combined with postoperative TS-1 treatment for T3-4 or N1 lower rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3 year disease free survival rate
Key secondary outcomes
local recurrence rate, pathological effectiveness, down staging rate, anal preserving rate, total survival period, safety, treatment completing rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
preoperative TS-1 treatment, preopeorative radiation, operation, postoperative TS-1 treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) pathologically diagnosed as rectal adenocarcinoma
(2)located in lower rectum
(3)preoperative diagnosis; T3-T4 or T2N1-2
(4)no metastatic lesion
(5)ECOG performance status; 0-1
(6)age between 20-80
(7)no previous treatment for rectal cancer
(8)normal vital organ condition
(9)oral administration is available
(10)informed consent
Key exclusion criteria
(1)drug allergy
(2)active multi cancer
(3)contraindication of TS-1
(4)major complication
(5)interstitial pneumonia
(6)pleural effusion or ascites
(7)fresh gastrointestinal bleeding
(8)positive HBs antigen
(9)treating docter judged incompatible
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ohkohchi |
Organization
University of Tsukuba, graduate school of comprehensive human sciences, clinical sciences
Division name
Organ Transplantation Gastroenterological and Hepatobiliary Surgery
Zip code
Address
Tennnodai 1-1-1, Tsukuba city, Ibaraki
TEL
029-853-3221
nokochi3@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichiro Murata |
Organization
University of Tsukuba, graduate school of comprehensive human sciences, clinical sciences
Division name
Organ Transplantation Gastroenterological and Hepatobiliary Surgery
Zip code
Address
Tennnodai 1-1-1, Tsukuba city, Ibaraki
TEL
029-853-3221
Homepage URL
soichiro@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 21 | Day |
Last modified on
| 2013 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005669
